Anyone have their boceprevir consent form handy?

I’m at work and got a message saying that I’m still detectable with a VL of 37 at week 12.  If I recall, the consent said that I would be notified between week 12 and 16.  I would be given the choice of dropping out or get the real drug open label.  This is assuming that I was on the placebo.  If anyone has time to look at the consent form to see if I’m correct or if there are other options I would appreciate it.

One other bit of info, is that I was undetectable (<5) on my first 2 attempts at treatment by week 12.  Perhaps it is the pegintron this time, where as the first 2 attempts were with pegasys.

[GreatBird]

Here's the part about the placebo arm:

Arm 1: Subjects in this arm will receive Peginterferon 1.5 mcg/kg and ribavirin, along with placebo. The arm is called the “control” arm.

• Lead-in phase: Peginterferon + ribavirin for  4 weeks (see above)
• After treatment week 4 (TW4), you will be given a placebo pill. This will be taken by mouth 3 times a day, in addition to your Peginterferon and ribavirin treatment.
• You will continue treatment with placebo, Peginterferon and ribavirin for up to 44 weeks.
• At TW 24, the amount of virus in your blood will be measured to determine whether or not you will be continuing the treatment after week 28:
o If the hepatitis C virus is not detectable (no hepatitis C virus measured in your blood), you will continue with placebo + Peginterferon and ribavirin treatment for a total treatment of 48 weeks.
o If the hepatitis C virus is detectable after 24 weeks of treatment, you will be discontinued from treatment at TW 28. If you are discontinued from this control arm, you will have two options.  You can either proceed to follow-up, or since you were in the control arm, you can choose to participate in another boceprevir study “PROVIDE” (where “open label” boceprevir will be added to your Peginterferon and ribavirin treatment). Your study doctor will discuss these options with you in detail during your discontinuation visit.

[can-do-man]

Difference between the navie trial and relapsers, i'm in the relapsers and at week 12 if not und then you have the option of going in the provide study where you get the real deal. You need to call your trial nurse and have them start you asap. Best to you

[zazza]

Looks to me like you were lucky to be detectable at week 12. This way you get the real stuff instead of having to go another round with SOC and perhaps relapse again.

[GreatBird]

Oh oops. My consent (above) is for naive. So ignore!!

[can-do-man]

I agree with zazza, if you had to draw the short straw its best to have a very low viral load at week 12 as now you know for the remainder of 48 weeks you will be getting the real drug. Hang in there bill, my first tx with SOC i wasn't even close to und at week 12.

cando

[Rockerforlife]

if the virus is detected after wk12,you will bediscontinued tx,this will not be later than you next visit @ wk 16.if you are discontinued from arm1,the control arm,you now have 2 options....you either proceed to follow up,or participate in another study' caleed "PROVIDE" where open label BOC will be added to your PEG/RIBA ..your doc will discuss these options with you in detail durinring your discontinuation visit.

[zazza]

Are you saying this would be a direct roll-over without discontinuation and restart? With a total of 48 weeks including the weeks already spent in the placebo arm?

[Rockerforlife]

BTW,,,,this PROVIDE trial is the first time its ever been do....i think....so you are still in ths ball game...BTW....your lucky you didnt clear at week 12 if your are in are 1...this way you get the real stuff...strange how it works?...your odds are still up there....call your nurse right away

[Rockerforlife]

im just called my nurse for some info...waiting for a call back...i will mention this roll over and let you know...i really dont know all the details either yet...but i will soon..from what ive been understanding is you just roll over into the BOC at you next visit right away

[can-do-man]

I was told tx would not stop and i had an understanding if i was not und at week 12 i could start the boceprevir as soon as my results came in and i was unblinded. They told me i would be ready to go by week 14 at the latest.

[nygirl7]

"if i was not und at week 12 i could start the boceprevir as soon as my results came in "

Wouldn't it make more sense to start it in the beginning? Like to stop SOC (with the sugar pill) and then wait a month and then start all three of the real drugs at one time when you should get the biggest bang?

Why do they think starting it so late will be of assistance is what I am wondering? Then you've only got like weeks 16 - 24 to get clear and it's so late already...

Did they explain any of that at all?

[Rockerforlife]

Well....i know one....after 12 weeks of SOC and you add the BOC,,,,and your VL IS AT 37?....you will be UN and hour later afetr taking the BOC....just my theory ....the monster will be in for a shock.

[GreatBird]

The Boceprevir Phase 3 trials all involve a 4 week leadup with the peg/rib. This gives it a longer leadup is all. Boceprevir has been shown to be more effective (in Phase 2) with that leadup.

[Rockerforlife]

its a trial and its written in stone....i guess its another way to test the BOC

[Rockerforlife]

THE LEAD IN works better than starting the with SOC/BOC together...they proved this....for some reason...its like kickn the virus when its down...a surprise left ...if you will....who knows...with this "12 week lead in"...it may be better...we will see in mid 2010

[Bill1028]

Well, it is official, I was getting the placebo and will be rolled into the open label arm.  The problem is that they are not ready and will not be ready until April 28th?!?!   I’m officially off treatment until then and they are not clear on the duration.  I will have to restart with the 4 week SOC.  The silver lining is that I will get the real drug.

[Rockerforlife]

April 8???...i dont understand why this part of the trial is nessessary...arm 1 that is...you say they are not clear on the duration...this dont sound right to me...talk about being blinded?.sorry to hear you got the pleb...just hang in there...im trying to figue ot why its done this way...

[comeagain]

It doesn´t sound right to me, restart if it is what cando said you gonna get the real stuff latest  week 14 they got to stick to that otherwise you can sue them I think.
Specially if you got that in writing!!!

Dont settle with that at once, cant you not at least continue soc until start, aweful long time BTW not ready until april 28 what kind of bull is that.

What isn´t ready do they have to manufacture more blue pills????

If the virus is down on its knees why give it a chance to rise again just don´t understand this.

ca

[Rockerforlife]

Now im thinkn they didnt want to say anything to us about this "rollover" in the beginning because i bet some peolple would not do the trial...just crazy thinkn here...even when i aske about this at the beginning no one seems to know....call shring mabe and see

[geterdone]

Are you able to continue taking the Riba and INF until April 8th or do they just give you enough until the next visit Or do you just stop all meds?

jasper

[Rockerforlife]

Lokks like by waht youre saying it you basiccly have to strat all over again from scratch.....anyone out there wrap thier head around this one?

[geterdone]

Probably not too far off the mark.

jasper

[comeagain]

On the other hand didn´t jim just posted something about restarting maybe could be a good thing I don´t know .
I´m gonna keep you in my prayers.

You how have relapsed more than once I really want you to succed.

Also think you will no mather what, i must say I also think your lucky that was detectable
week 12.
Ram and Greatbirds who are nullresponders and cando and rocker how hasn´t responded as well as you( not sure about rockers respond first tx) they all seems to kick the virus down big time, so Man if you gonna get the blue pills the viros want stand a change.

Good luck and best wishes!!!

ca

[Rockerforlife]

Well if this is the case...how can one back out now...i think if it was me....i would not drop out now....i would want to get the BOC anyway i could

[Rockerforlife]

Maybe this why they did this....jims post earlier on the restarting and stopping therory..is what they are doin...here goes my crazy think again....anyway you slice this ...you are gonna get  the BOC...so you will be ok...you had a good response to the SOC this time....not waht you wanted,...but you are not down yet...far from it...still waiting for my doc to call

[geterdone]

Wait a minute this may be a good thing, in your prior 2 treatments you did respond and achieved und by week 12 with pegasys and now with pegintron down to a vl of 37 so to me both of the pegs have worked. Ok so you’re a gym locker, the important thing is both pegs do work so if you can do the rollover and have to start with the peg/riba for the first 4 weeks and then add in the boc (the real deal) it just may put you over the top with the disinfectant knocking out the more stronger virions. Stay positive all in not lost in the gym. Rocker was thinking the same thing on the cycling.

jasper

[comeagain]

I´ve been thinking a bit more also talking with someone else about your situation.
And the thing is this meds boceprevir are so new and has maybe never been checked out how it works after 14 weeks of soc.

It can be much more complicated than i first thought, it could be about factors like importens of hitting it relativily fast, you know mutation and when the virus return to its wild form etc.

Don´t think there is so many how know much about this here on forum perhaps willing or mr liver or someone.

Bottomline is maybe they know exactly what their doing by giving you a break and then start new  at april 28.

[willing]

oy vey, the woes of a labrat are more numerous than the starts above.. Sorry about getting pulled. Three months shot! It certainly would be preferable to just add the real blue pills and keep steaming ahead, effectively getting a 12w lead in.

[Rockerforlife]

This was y thinkn....after wk 12 if you didnt clear you would be rolled over into the BOC....waiting till April dont sound like no rollover to me...more like stop and start over....i bet if this was known befor the trial started....some would have backed out...i would like to know the truth here

[Bill1028]

There are a lot of things that don’t make sense about his whole thing.  There is enough blame to go around between the hospital, lab, and the drug company.  These are the chances that you take when you do a study.  I’m just glad that I did not go undetectable at 11.5 weeks and then do 48 weeks to find out that I was in the placebo group.


Always Look on the Bright Side of Life (from Monty Python)

words and music by Eric Idle


Some things in life are bad
They can really make you mad
Other things just make you swear and curse.
When you're chewing on life's gristle
Don't grumble, give a whistle
And this'll help things turn out for the best...

And...always look on the bright side of life...
Always look on the light side of life...
If life seems jolly rotten
There's something you've forgotten
And that's to laugh and smile and dance and sing.
When you're feeling in the dumps
Don't be silly chumps
Just purse your lips and whistle - that's the thing.

And...always look on the bright side of life...
Always look on the light side of life...
For life is quite absurd
And death's the final word
You must always face the curtain with a bow.
Forget about your sin - give the audience a grin
Enjoy it - it's your last chance anyhow.
So always look on the bright side of death
Just before you draw your terminal breath
Life's a piece of ****
When you look at it
Life's a laugh and death's a joke, it's true.
You'll see it's all a show
Keep 'em laughing as you go
Just remember that the last laugh is on you.

And always look on the bright side of life...
Always look on the right side of life...
(Come on guys, cheer up!)
Always look on the bright side of life...
Always look on the bright side of life...
(Worse things happen at sea, you know.)
Always look on the bright side of life...
(I mean - what have you got to lose?)
(You know, you come from nothing - you're going back to nothing.
What have you lost? Nothing!)
Always look on the right side of life...

[GreatBird]

Thanks for the song. Surely one of the best cinematic moments there is. :)

[Rockerforlife]

n The Beginning"

[First Man:] I think, I think I am, therefore I am, I think.

[Establishment:] Of course you are my bright little star,
I've miles
And miles
Of files
Pretty files of your forefather's fruit
and now to suit our
great computer,
You're magnetic ink.

[First Man:] I'm more than that, I know I am, at least, I think I must be.

[Inner Man:] There you go man, keep as cool as you can.
Face piles
And piles
Of trials
With smiles.
It riles them to believe
that you perceive
the web they weave
And keep on thinking free.